PMA P010020S010
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S010
- Product code
- MIP
- Decision date
- 2008-08-08
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- UTILIZATION OF AN ADDITIONAL FABRICATION SYSTEM IN THE MANUFACTURING PROCESS OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S010
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2008-08-08
- Decision code
- OK30
- Date received
- 2008-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UTILIZATION OF AN ADDITIONAL FABRICATION SYSTEM IN THE MANUFACTURING PROCESS OF THE DEVICE.